AQUABEAM ROBOTIC SYSTEM
Received Jan 8, 2026 · Event occurred Dec 19, 2025
Report 3012977056-2026-00005 · MDR key 24004437
Device
Product problems
- Visual Prompts will not Clear
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE AQUABEAM MOTORPACK MALFUNCTIONED, DISPLAYING MULTIPLE ERROR MESSAGES. AS A RESULT, THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
COMPONENT CODE = 4756, AQUABEAM MOTORPACK, A REUSABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM. ROOT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY IN PROCESS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Additional Manufacturer Narrative
THE AQUABEAM MOTORPACK NOT RETURNED DESPITE MULTIPLE FOLLOW UPS. THE EVENT COULD NOT BE CONFIRMED AND ROOT CAUSE REMAINS UNDETERMINABLE DUE TO THE INABILITY TO INVESTIGATE THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 23C10270 AND AB2000/B SERIAL NUMBER (B)(6) WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE SESSION LOGS WERE REVIEWED AND THE REPORTED ERROR CODE COULD NOT BE CONFIRMED. THE AQUABEAM ROBOTIC SYSTEM USER MANUAL, UM0101-00 REV.F. STATES THE FOLLOWING: MOTORPACK USE IS DETAILED IN THE AQUABEAM USER MANUAL IN SECTION 4.3: ENSURE THE MOTORPACK MAGNETIC LATCH IS POINTING TOWARDS THE BLACK INDICATOR. CLEAR ANY EXCESS DRAPE AND SEAMS OFF THE MAGNET PLATE ON THE MOTORPACK. PATIENT/USER INJURY COULD OCCUR WITH UNANTICIPATED MOVEMENT OF THE MOTORPACK. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.